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Truthfan, is the a required puzzle piece that just fell into place or is this a nice to have addition?
AK - my recollection was this is the supply chain automation vendor hired for DCVax production and distribution connectivity.
I agree Flexroy and try to use what little pulpit that I have. When I talk these things, some people just swipe me away in an instant.
DD, what are those nee terms?
We should probably get to NASDAQ before giving approval news.
Thank you Chiugray. I have actually begun to do this meditation regularly now.
I wish they hadn’t pulled down my piece about the Hopi Sacred Clowns. It hit too close to home I guess and that editor on the other side swiped it before I could edit again. Maybe I’ll try to finesse it for you.
I am not at all involved in the details of what is going on with Flashworks, but do remember it being a big part of what propelled us to $2.50 without any new data whatsoever. What happened to all that excitement and confidence in our fine leadership? Who went on a campaign to castigate and create unfounded doubt? How did they do it? Were they alone? Who else aided and abetted them?
The point for me having watched many a drug launch from within and without is that you have time before demand ramps up. Even for the greatest of breakthroughs time is necessary because all of those patients whose tumor has already been rescected and not put on ice, cannot get DCVax. All those neurosurgeons and their teams need to put protocols in place to properly obtain and process the extracted tissue. Clinical research side of an institution really has almost nothing to do with the clinical care side of the institution.
We have several months to get everything right and in place to meet the coming demand. Flashworks has time to incubate, no reason to rush the baby out the door.
I believe it is DOJ working on that sheet metal curtain right now. They will find many the artificial Oz when they do and all of their Lillyputian foot soldiers as well.
It will be a glorious day when we break through all their tiny little string that have been keeping this Giant lying on her back. When she stands tall and she shouts victory, it will be a whale of a sound that carries far and wide from sea to shining sea and then across the pond where we will let Freedom ring. Freedom to live a longer and better life than we once did as a one human people.
And December 29th 2022 will be 815 days? Your point?
The only measure worth watching is approval. They are well within ‘normal’ operating timelines and this is a global pandemic we are within.
Umibe, I think most people assume that the originally randomized cohort comparison for survival is mOS. I believe this very well could be positive, but what if it is Hazards Ratio and includes the very long tail of data, or what if it is a proportional analysis?
IMO the original cohort survival analysis is positive. In which case, who gives a damn about the original PFS? It is a surrogate marker for death and it will be proven meaningless for personalized dendritic cell immune therapy for brain tumors. Know any drug that NWBO plans to market which meets that definition? Oh, there is just one?
So then, why still include it? Well, perhaps you want to prove to any and all that it is meaningless, but that the adjudicated PFS is not. That begs the question of order. If you believe that the most difficult hurdle is the one with likely much confounding issue that poorly correlates with survival which is all that really matters, then why third before such important 4th and 5th measures?
It seems to me to be a clue. One that may mean the order is completely irrelevant after the first and primary endpoint. Or, perhaps based on all that beyond study data that they possess, like watching vials from one pile disappear but the other pile slowly, then suddenly stops moving down. Maybe they already know that answer, but have an even better one. Who knows?
Linda and Linda, Max and Robert, Keymours and Timothy.
All I know is that LL was downright excited to talk to those outstanding neurosurgeons at another pinancle of medicine back in May, and she was quite confident in when she was leading them next. She was also quite confident when she told her colleagues to please start properly saving tissue, despite the out of pocket expense to vulnerable families.
Thank you for watching on our behalf, Senti with your keen eye and attention to detail. Have they released in batches before?
If not,what is the pattern? There almost always is one. Are there two fast one medium and one slow, for example?
I am going to miss this message board some day soon. I will pop back in as we all will until NWBO is no more and they become part of someone bigger or perhaps they can become Gilead then Roche, then Tesla, then something new.
Hopefully many of you will choose to join me with DTIL. I am committed to that journey too, once I have more time and much, much more money. I really like this game that we have all played together. Even the other side, as they made us all stronger and smarter and ultimately wealthier.
I will be wiser then next times because of all of you. And Linda and Linda et al. Even DI too.
Biosect, Memes aren’t my thing, the kids these days move too quickly for me. It took me a minute to get it but me likey.
It is like a Zen meditation to get through these dips. Be the dendritic cell, watch it create killer T cells while you hold the weight, anger and anxiety back and focus on that T cell killing those tiny tentacles left behind by the precision blade of the great Linda Liau and her healing hands. Watch them blast three shots of poison, two to get in and one to shrivel up the nuclease and cell itself. Then watch it fly away home. See the light that it goes back to. That light within you. Within each and every one of us. Let it grow more powerful as you attach your light to Linda’s light. Then to the other Linda’s and Marnix and Robert And Keymours, then to Flipper, Doc Logic and Biosect…Iwasadiver, Kabunashi, and Ike Equire,…to Senti, Chiuguy, and GoodGuy…to Poorman, Bright Boy, and of course Lykiri…then to many, many more. To all those we know, all of our minions…feel that light, feel that energy…let it lift you up, give you strength…allow it to go back to that T cell, and back to that Dendritic cell, back to Dr. Liau’s lab, then to her knife. Take it back to that tumor which is no longer there, follow it out of that skull…
And look into that smiling face…the one that has been given more life, longer life, more time with friends and family and children and grandchildren.
Remember that face and now picture it as YOU.
That is what that meme says to me
DD, I love this line and am going to commit this metaphor to memory…thank you
IMO it is a trial and would require patient consent. The drug is not approved to market and that is Europe anyway, so you can’t charge for it. I don’t believe they are using an EAP there although ‘specials’ is essentially the same.
People do realize that an approved specials program means the regulator already believes the drug to be safe and effective, right? By regulation, right?
What is missing is manufacturing certification and a formal approval. Not much more than that. We know they already approved the new endpoints so do your own math…mine is saying January or February there too. Everything just seems to be coming together for some very big news to hit the market in Q12022.
FDA never provides public clarity and rarely gives full clarity to anyone in private. You can’t update a website without that clarity, and to do so while in process or while running a coming soon campaign give away a lot, especially since they chose to do the more hazy pathway.
I know there are still skeptics of ‘coming soon’. All I can say is that what keeps adding up in terms of marketing is not something that regulator would allow to continue even for companies a little bigger than 16 employees and pennies on the dollar of value. They may not lower the boom, but they would stop it. So even if it is turning a blind eye and not a 6 month window, a blind eye speaks volumes.
Don’t you think the helmet would and has formally complained about these activities? The world we live in is not a bubble.
Not my area of interest. I trust others to read and interpret this stuff. I do trust the opinion of many here
She is under binding contract not to say anything and she is an ally…you dig?
Nothing tangible. All developments since Oct 2020 have been positive and moving in the right direction. Right down to the $15M loan with pretty decent terms that constantly gets FUD. What exactly is bringing this stock down?
That is a question that may be answered by DOJ and their investigation, with the help of Cofer and that Texas Lawyer Dude. Quake
Am I reading this correctly, dated 25 October 2021?
ILT, Not sure I understand what you are saying. I did my best to read the posting but I am not on Twitter so I don’t even know what you are talking about. Are you saying that the whole add this Unbranded piece to the campaign is bogus or that I missed the additional verbiage that accompanies what I saw?
It is Unbranded so they have latitude, however, those things are claims and the unbranded nature is a thin line. A more vindictive regulator could interpret that differently but a collaborative regulator may not.
BTW you are right in calling this a circular as it is NOT a journal. That too has implications which are minor but adds to the picture of what we are seeing. Who has access to this circular? Do patients?
You can’t do any sort of branded marketing to patients until 6 months after approval for a new technology.
Sukus, Holy Crap! Are you telling me that between the ABTA program advertisement and the crazy banabas Dendream tote bag, they take out another ad talking about hope for patients and showing an MRI image of the brain with tumor enhancement in the right temporal lobe.
Now, notice that the ad does not say DCVax (R) which would limit any kind of alluding to anything beyond, but they are still talking about dendritic cell therapy with a Brain tumor image nearby. This is getting very close to stepping back into Branded, because they only have one DCVax for brain tumors, but it probably gets a pass. It still looks a hell of a lot like a campaign to me. I mean piece one right after another and they are doing multichannel, multimedia. But they separate some ideas from each other.
Alright, let me hear ya…One, two, three strikes your out at the old ball game.
I don’t see those words under the ad though but maybe I am missing something
Dude, my poor friend, those primary endpoint statistics alone won’t be understood by lay public. They need a publication or presentation to give physicians even enough to contemplate the victory. How do you discuss a primary with three unique and advanced statistical design elements?
The timing of publication and approval will be happenstance in my mind. FDA and regulators work on schedules and timelines. Which would you work on first if you had limited resources and time, the approval process or a publication?
They can work on both but you only have one top priority. Money, money, money…money. And they need it desperately. What kind of revenue does a publication produce?
Go on past Aug 21 2015 - check with regulators on process.
Go past Feb 6 2017 - inform regulators and check opinion.
Go past Nov 2018 - work on new document to submit to regulators as well as new subtyping to ensure accurate designations
Go past Oct 5 2020 - work on submission to regulators and work on a publication for appropriate digestion of the facts in this case, brother.
The great and wonderful Dr. Linda Liau showed us the model design and showed us the SAP design. How much time do you think it would take after that? They had time to get started on remaining elements while she made her way to Mt. Sinai…and yes HappyLibrarian… Mt. Sinai is a religious based institution as well as the mountain top where Moses brought us the Ten Commandments. Though shalt not steal. Though shalt not bare false witness.
Happy, Are you saying Linda Liau has done at least one and a party to both?
I am running out of posts Poorman and need to be efficient, my guess is Happy is still reading my voice.
My best guess backed by simple math on mOS along with concerns of the Unadjudicated PFS is one for two.
But those no longer matter to me.
Overall 4 of 6 is in the bag, 5 of 6 is likely, and 6 of 6 is quite possible, very much in the game. The only question mark that could eliminate that 1 is how do you handle those placebos who crossed over before switching to DCVax(R)?
This is why you can bet FDA is in this game. The fairness of Intent to Treat here is no good for anyone good.
You think that comment and song was to NWBO.
You misunderstand
That devotion was to the GREAT Dr. Linda Liau, savior to many already and many more to come.
Only love can leave such a scar, only love, Only love can heal such a mark. Just a fire til we die you and I will magnify.
MAGNIFICENCE
Bare in mind also that I am assuming a package was not presented until 2021
Think about this, Flipper or Senti or Doc, I can’t remember who because they is no voice told me there, is an accepted statistical analysis that allows you to carry alpha beyond primary but divide it up and still remain at 0.05 for 2-6. I am not certain but there should be. So what if you don’t need to cross a more narrow 0.01 and you don’t have to be right in the right sequence.
What if the original PFS is irrelevant. I will give an example. If disability is seen in a relapsing remitting disease, it is not called permanent or sustained immediately. They recheck in the future to confirm this. Usually this is before analysis, but can be post hoc too. They usually do sensitivity analysis and check by 3 or more methods, like lets say at 3 months or 6 months or forever more.
Put that in you brain and spin it round and round again.
What if the equation I posted in June of 2017 or 18 is close to correct as a reasonable estimate. Then mOS hits. What if carrying it out and instead doing proportional hazards type stuff makes it even more certain. What if rGBM hits. There is a lot to consider but new primary is a dead head lock in my opinion.
Jtaylor here is a belief of mine separate from any other thread.
I give you my opinion as a person, not representing anyone else. If you can accept that then continue reading below.
I am not a financial anything for anyone but myself and maybe some family. I am not a physician and do not practice anything licensed despite having a license in healthcare. I do not give anyone anywhere any permission to view this message and anyone referenced directly or indirectly by this and connected messages, as anything but private opinion and ASCO proves I can be wrong. I am not an attorney and while I may give my analysis of the law, I do not practice law and none of you are my clients in any way. I may or may not now work in the Biopharmaceutical industry, but do not give anyone permission to view that as me speaking on behalf of any company or regulator anywhere in the world. I am providing this as an alias and claim artistic license and will draw from history and media for purposes of illustrations of my private opinion and this does include you tube and authors of great works. I may be adapting concepts but I am not speaking on behalf of anyone and endorse no one at this moment but family and very close firends.
The full page advertisement to physicians reads disease, mechanism and registered trademarked brand name. Some or all of these are missing from previous endeavors with exception of scientific session. I did not walk the booth, see any full renditions, speak to anyone there or much else related. FDA has been lenient there anyway, but for only so long and deep. ASCO 2019 is different it is on Youtube or was for a long time. They removed the booth.
So yes, I believe those two bags and scenarios are dramatically different. Perhaps, I am wrong or FDA or some other regulators need more time.
Where religions intersect, you will find your maker.
Medicine is also a religion to physicians.
FWIW I too agree with what Umibe has been saying lately, whole-heartedly. I think the strategy to go real long was a painful one, but in the new world it will create a long term barrier to entry for anyone but them. They now own GBM for a very long time.
IkeEsq, Thank you for the excellent analysis. I have some additional questions for you if you don’t mind.
If shares are naked to a huge degree and those HFs get taken down with criminal charges, can there also be a civil suit?
How are those holding counterfeit shares reconciled and compensated?
Does it matter at what price you bought phoney shares iif stock price hits the roof?
How does anyone know which shares are counterfeit and which are real?
Why isn’t counterfeiting illegal with stock on a criminal basis?
The intent for MMs to be able to go naked short is for short time relief and temporary settlement flexibility. If there are 300 million naked short shares for example and that number kept growing and never falling, when, if, or how does that cross a line?
Totally agree. They are only a little vindicate when you blatantly defy them as they should be. They are regulators and that doesn’t just mean evaluating and approving, it means enforcing laws meant to keep charlatans from pushing snake oil or overstating efficacy, minimizing safety (that is a big one), and making comparison that can’t be made.
The last one is interesting to think about in the new world. Do we really ever need comparison studies in ndGBM? Now you need to prove your salt first in recurrent GBM, notice the recent companies path for new products, and if you do you may be allowed some day after a lot of long term experience you may be able to challenge DCVax. But not before then because Linda took us out very far to prove a point which will be very hard for others now to prove.
If you are all comparing to the same randomly captured, matched database that gets close to a defacto comparison.
Even when you do break rules they usually start small and get bigger and bigger if you just wont learn your lsson or you step way out of line. Premarket promoting a drug in review gives the market the impression the drug has been approved when it has not. Think about a drug with other indications, that could be downright dangerous. They try to be consistent too unless that is not really good for patients.
That is why you can only do it with their permission, a permission they don’t always grant. They too are interested in getting real advances in the bodies of patients as quickly as possible and a little ‘coming soon’ helps when you are pushing to get across a finish line where the race has already been called. Now lets say you are trying to remain stealth about it, then you choose the first path rather than the obvious second path by actually saying ‘coming soon.’. They give you a choice but you can’t do both or too much and they are watching. If you make innocent mistakes anytime, they handle you softly. But they do stop you.
That is the real value of the tote that gets mocked…it is rather stealthy and one that could just get a stinging slap. But the full page add is more and complete, because of that, the tote is confirmation of no slappy slappy has gone on.
It is only a tote…are you serious? Yes, quite serious actually because it came second.
Pubs generally take 6-10 months when right the first time, and may be shorter for something really hot but NEJM has a lot of great stuff to sort through and get out. There is a line and it is really hard to jump it.
That is still right on schedule from May-June start in my mind. I think the first pub was ready in April, but it is the second pub we all want to see.
I think we saw the first domino foreshadowed today, the next is certification, then approval, then publication, then shorty gets his day in court.
I think were are going to be ecstatic, then shouting for joy from the mountain tops of Tibet, and then…well then is when we see the “game start” aftershock which will quite literally rumble the earth from wallstreet to San Diego, Miami to Seattle, and everywhere in between with an especially long stop In Chitown baby. NWBO is far from the only company getting in on this baby. They got cash, well added up the good guys have a lot of cash too and more coming when they win.
I understand and read the article. What I was thinking was that Texas Lawyer Dude who had an hour plus Youtube about all the different ways he brings down shorty. I was thinking about his sightings with Linda et al. Add to that the splash of Cofer Black that I had not heard before and that seems downright scary.
When you say believed to be true, I assume you are talking about fraud. If instead you look at it as collusion and criminal conspiracy then you are talking a whole different ballgame, and you don’t need to be aware laws were broken in the process to be implicated and guilty…for Hoffman…as far as I know.
Maybe PQR or IKE et al can give us a little insight into those to babies. It seems to me there is something similar to price fixing going on, and that DOJ and Cofer can drum up one or two criminal charges. I am pretty damn certain, Texas Lawyer Dude can connect all the dots that must be connected, especially with Cofer by his side.
For a man once ridiculed by the other side, I can’t stop saying Cofer. I think I am going to figure out how to turn his name into a Homonym in my vocabulary for something bad ass.
Words like Homonym make me start singing in my head
Conjuction junction what your function…kids these days don’t get school house rocks
Oh yes, I believe he has got them by the cohones and isn’t going to let go. Man this team is smart. I am so glad that I trusted in them. I am going to have so much SCHADENFREUDE here that my joy will last for a very long time, actually the rest of my life.
Just recall all those taunting posts about Cofer…he who laughs last!
Absotutely SK-REWED! SCHADENFREUDE! I have it already.
I wish that I could share some side bar information with you but I can’t. These B-stards have been holding back and destroying technological advance for years and getting away with it.
People are literally suffering and dying because of them. If and you know what, they get caught up in this regarding NWBO, I hope DOJ considers murder charges on behalf of the thousands of GBM patients who died unnecessarily because of what they did.
I hope a certain popular TV host goes down in flames along with them…maybe not here but many other places
SCHADENFREUDE
Bingo AK, I was focused on release at SNO because I am an HCP, but I think you are damn right about the 10Q as well. They had to release to medicine by SNO. They have an active clinical study and the Specials program where even if AK and LL were already informed, patients and their referring physicians were not.
Everyone please read this post from Sojo instead
Thanks for that Sojo…I am slow with technology issues.
This is a very big deal to me…likely why we haven’t seen LC for a while actually
Oops I assumed but this isn’t the tweet I though you posted. Will post momentarily
Everyone please read this post from DD…you too Ex.